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FDA approves new dosing for Faslodex for breast cancer

AstraZeneca announced that the FDA has approved the 500mg dose of Faslodex (fulvestrant) injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. This approval was based on data from CONFIRM (COmparisoN of Faslodex In Recurrent or Metastatic breast cancer), a Phase 3 study which demonstrated that Faslodex 500mg reduced the risk of disease progression (assessed as progression free survival) by 20% (p=0.006) when compared with Faslodex 250mg. Faslodex 500mg significantly increased median progression free survival to 6.5 months vs. 5.4 months with 250mg (p=0.006).

Objective Response Rates calculated in patients with measurable disease was not significantly different between Faslodex 500mg (13.8%) and 250mg (14.6%) (p=0.795). Median overall survival was 25.1 months with Faslodex 500mg and 22.8 months with 250mg (p=0.091). At the time of analysis, overall survival was not statistically significant. A pre-planned second survival analysis will occur as data mature when approximately 75% of patients have had an event.

Faslodex 500mg will be supplied as 2 x 250mg/5mL packaged together in early fourth quarter 2010. During this time, Faslodex 250mg will still be available.